In collaboration with other compliance professionals, develops and executes the Compliance Plan and Strategy for DFCI. Manages the process by which the Compliance Oversight Committee develops priorities, and monitors compliance effectiveness. Coordinates and facilitates all Compliance Oversight Committee activities including reporting activities of the compliance program

Delivers expert, evidence based nursing care to patients and families. Implements nursing process Assesses patient and family needs. Analyzes assessment data to develop and support clinically accurate diagnoses. Plans care by establishing goals with measurable outcomes. Implements the plan of care. Evaluates the patient's response to interventions. Documents care accordin

The Research Project Manager II will work independently under general supervision of the Zakim Center's Senior Clinical Research Manager. This position may be responsible for some or all of the following Responsible for day to day oversight and management of assigned projects. Responsible for development and maintenance of regulatory documentation. Assists PI with protoco

The Research Project Manager I works independently under general supervision of the Zakim Center's Senior Clinical Research Manager. This position may be responsible for some or all of the following Day to day oversight and management of assigned projects Maintenance of regulatory documentation and submissions Facilitation and oversight of research project start up, activ

Conducts resource assessment with patient and/or family in light of patient responsibility for pharmacy expenses and capacity of patient and/or family to meet that financial responsibility. As member of multidisciplinary team, assists patients in securing pharmaceutical assistance through skillful matching of needs to available programs. Identifies appropriate resources f

Practices in accordance with all federal and state regulations, DFCI policies and Joint Commission standards. Responsible for designated daily operations and/or clinical activities of assigned area. Appropriately dispenses pharmaceuticals, including sterile products, chemotherapy, biologics, controlled substances, and investigational medications. Evaluates all providers'

Practices in accordance with all federal and state regulations, DFCI policies and Joint Commission standards. Responsible for designated daily operations and/or clinical activities of assigned area. Appropriately dispenses pharmaceuticals, including sterile products, chemotherapy, biologics, controlled substances, and investigational medications. Evaluates all providers'

Provides administrative support and coordination for all aspects of patient care for both new and/or established patients. Schedules appointments following guidelines that support continuity of care and a high standard of timely communication and rescheduling as necessary. Appropriately arranges resources to support the highest standard of patient experience and visit, i.

Pharmacy Technician Duties Practices as a pharmacy technician in accordance with all federal, state, DFCI and Joint Commission policies, regulations and standards. Fills medication orders according to policy, while gaining proficiency with advanced preparations. Ensures timely delivery of medication orders and/or supplies. Utilizes multiple systems such as EHR (Electronic

Orients and assists in training new staff. Qualifications Bachelor's Degree and 1 3 years of equivalent experience required. Experience working in a medical or scientific research setting or comparable technology orientated business environment preferred. COMPETENCIES Demonstrates understanding of CRF completion, including timely and accurate transcription of study data S

Cell Processing Process More than minimally manipulated clinical human therapeutic cellular products by various methods using manual and/or automated aseptic technique in a regulated clean room environment according to standard operating procedures and applicable regulations. Achieve and maintain competency in routine procedures including cell culture, including aseptic t

No supervisory responsibilities. Normally receives general instructions on routine work, detailed instructions on new projects or assignments. Qualifications Bachelor's Degree required with a major in biology or chemistry preferred. Typically requires a minimum of 1 4 years related experience. Developing technical expertise, applies Institute policies and procedures to re

Evaluating and tracking the eligibility of all patients seen in the clinic for inclusion in the study. Maintaining on going communications with Information Services and physicians and staff for data collection needs. Reviewing and abstracting the medical records for patients. Entering the clinical data into the study database. Accessing patient demographic and clinical in

Regulatory Compliance Prepares and submits all protocol applications, amendments, continuing reviews, and informed consent documents for SRC and IRB review and approval Prepares and submits regulatory documentation that may include; IND/IDE applications, FDA annual reports, Serious Adverse Event reports, to the appropriate regulatory agencies including the Food and Drug A

Regulatory Compliance Prepares and submits all protocol applications, amendments, continuing reviews, and informed consent documents for SRC and IRB review and approval Prepares and submits regulatory documentation that may include; IND/IDE applications, FDA annual reports, Serious Adverse Event reports, to the appropriate regulatory agencies including the Food and Drug A